Temsirolimus - Intravenous

Temsirolimus is used to treat advanced cancer of the kidney.

It may also be used to treat mantle cell lymphoma (a type of cancer affecting the lymph nodes) that has returned or is not responding to treatment.

Temsirolimus injection is to be given intravenously (into the vein) as an infusion. It is delivered directly into the bloodstream via the blood vessel.

Your doctor or nurse will administer the injection for you.

Before starting your treatment, you may be given other medicines to prevent or lessen the side effects of Temsirolimus.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the course of treatment depending on the type and severity of your condition and your response to the medication.

Ensure that you keep all appointments with your doctor so that you do not miss any doses. Your doctor also needs to regularly monitor your response to Temsirolimus.

If you miss an appointment or miss an injection, alert your doctor or nurse. A replacement appointment or injection should be given as soon as possible.

Do not use Temsirolimus if you ever had an allergic reaction (e.g. rashes, breathlessness, swollen eyes) to this medicine or similar medicines such as sirolimus.

Alert your doctor if you have moderate to severe liver disease as Temsirolimus may not be suitable for you.

Inform your doctor if you have the following conditions:

• diabetes
• cancer that begins elsewhere in the body and spreads to the brain
• mild liver disease
• high level of cholesterol in the blood

Let your doctor know if you are pregnant or planning to become pregnant.

Both men and women must use proven birth control methods during Temsirolimus therapy and for 3 weeks after stopping the treatment. You may wish to discuss birth control methods with your doctor or pharmacist.

Let your doctor know if you are breastfeeding. Your doctor may advise you to discontinue breastfeeding during treatment and for 1 week after the last dose of this medicine.

If you are going to have an operation, including minor surgery and dental work, inform your doctor or dentist that you are using Temsirolimus.

Inform your doctor if you have been recently vaccinated. Do not receive any vaccinations without first asking your doctor. Also, avoid close contact with people who have been recently vaccinated.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy tests must be done before treatment to know if this medicine is suited for you to use.
• Routine tests (e.g. complete blood count, liver and kidney function, cholesterol and blood sugar levels) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of signs and symptoms of increased blood sugar levels (e.g. excessive thirst, increased volume or frequency of urination); allergic reactions, and infusion-related reactions may also be needed.

Temsirolimus may cause any of the following side effects: headache, nausea, diarrhoea, vomiting, mouth sores, generalised weakness or lack of energy, muscle or joint pain, back pain, numbness or tingling sensation in the hands and feet, nail disorders, dry skin, itching, sore throat, stuffy or runny nose, altered taste or loss of taste, difficulty sleeping, anxiety, and depression.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• signs and symptoms of allergic reactions e.g. rashes, breathlessness, swelling of the face, eyes or mouth
• pain or difficulty in passing urine, change in how much urine is passed, blood in the urine
• signs and symptoms of serious lung disease e.g. shortness of breath, unexplained weight loss, chest pain, coughing up blood
• confusion, drowsiness, flushing, unusual thirst or hunger, increased urination, flushing, rapid breathing, or fruity breath odour
• severe stomach pain, high fever, black, tarry or bloody stools
• unusual tiredness, difficulty in speaking or swallowing, uneven size of pupils

This medicine may cause the level of your red blood cells, white blood cells and platelets to drop.

Red blood cells carry oxygen around your body. A fall in the level of red blood cells may make you feel tired and worn out.

White blood cells help your body to fight infections. A fall in the level of your white blood cells may put you at higher risk for infections, such as coughs, colds and flu, which may lead to more serious infections. Avoid crowded places and people who are sick. Inform your doctor if you have a fever, cough, or flu that does not go away.

Platelets help your blood to clot when there is a cut in the skin. A fall in the level of your platelets may put you at risk of bleeding more than usual. Do not take part in activities where you may fall or get injured, such as contact sports. Inform your doctor if you get any unusual bruising (large bruises or several bruises, especially if the bruises appeared on their own) or bleeding that takes a long time to stop (for example, too much bleeding when you floss or brush your teeth).

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor and pharmacist if you are taking any of these medicines:

• other medicines for cancer e.g. sunitinib
• medicines for high blood pressure e.g. ramipril, amlodipine
• medicines for epilepsy (fits or seizures) e.g. carbamazepine, phenytoin, phenobarbital
• medicines to treat TB (an infection known as tuberculosis) e.g. rifampicin
• medicines for fungal infection e.g. ketoconazole, itraconazole, fluconazole
• medicines for HIV infection e.g. nelfinavir, ritonavir
• certain antibiotics e.g. clarithromycin, erythromycin
• blood-thinning medicines
• aprepitant (medicine for nausea or vomiting caused by cancer medicines)
• nefazodone (medicine for depression)
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Temsirolimus.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Avoid excessive consumption of grapefruit or grapefruit juice (more than 1 litre a day).

Store in a refrigerator, between 2-8°C. Do not allow Temsirolimus to freeze. If frozen, this medicine will become ineffective and should not be used. Protect from light.

Medicines must not be used past the expiry date.

As this is a cancer medicine, unused or expired medicine must be returned to the clinic, hospital or pharmacy for disposal.